D-0768-2022 Class II Terminated
FDA drug recall D-0768-2022 was initiated by Preferred Pharmaceuticals, Inc. on Mar 23, 2022 and is designated Class II. Reason for recall: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program. The recall status is terminated (terminated May 4, 2023). Affected quantity: 1568 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 20, 2022
- Initiation Date
- Mar 23, 2022
- Termination Date
- May 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1568 bottles
Product Description
Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01
Reason for Recall
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Distribution Pattern
IL
Code Information
Lot #: A0721O, A1421Y, A2121G, A2821D, B0421H, B0421I, B0521U, B1121G, B1921C, C0421B, C1821N, L0120F, L2320O, L3020T, Exp.: 4/30/2022; B2521A, C1121S, C2521U, D0121S, D0921B, D1421B, D2921C, E0721A, Exp.: 10/31/2022; D2221A, Exp.: 12/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0768-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026